Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy
Primary Purpose
Head & Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PET/MRI of carotid arteries with 68Ga DOTATATE
Sponsored by
About this trial
This is an interventional diagnostic trial for Head & Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- previously treated with radiation for head and neck malignancy;
- Age Group: ≥30 years;
- Patients who have no contraindications to PET/MRI;
- No allergy to contrast agents.
Exclusion Criteria:
- Pregnant females;
- Age group: < 30 years;
- Allergy to MR contrast agents;
- Pacemakers/ICD/Claustrophobic patients.
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/MRI scan with 68Ga DOTATATE
Arm Description
PET/MRI scan with 68Ga DOTATATE of carotid arteries in in patients following head and neck radiation therapy
Outcomes
Primary Outcome Measures
Validity of PET/MRI with 68Ga DOTATATE of carotid arteries
Macrophage activity detected by 68Ga DOTATATE PET/MRI of carotid arteries in patients at risk for vascular events post radiation of head and neck squamous cell carcinoma.
Secondary Outcome Measures
Full Information
NCT ID
NCT04040166
First Posted
July 29, 2019
Last Updated
October 31, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04040166
Brief Title
Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy
Official Title
PET/MR of the Carotid Arteries With 68Ga DOTATATE in Patients Following Head and Neck Radiation Therapy and at Risk of Cerebrovascular Events
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The improvement of comprehensive multi-modality treatment and radiotherapy (RT) technology has resulted in an improved survival rate of head and neck malignancies within recent decades. As survival increases, late toxicity from cancer therapy becomes a larger burden. Radiation induced vascular injury following RT is a recognized complication of radiotherapy. Diagnosis of vascular changes predominately relies on non-invasive imaging techniques. Doppler ultrasound assessment has been proven as a good indicator of diffuse atherosclerotic disease and a significant predictor of future vascular events. New opportunities are provided by the recent introduction of the hybrid PET/MRI scanners for investigating the synergistic effect of these two modalities without the challenge of image co-registration. It has been shown that the PET system integrated with the MRI scanner performs the same as the PET portion of a PET/CT for various cancers and cardiovascular indications. MRI allows better delineation of the carotid artery and atherosclerotic plaque when compared with CT due to the superior soft tissue contrast. The PET/MRI system acquires the PET and MRI simultaneously allowing for perfect alignment between the 2 sets of images, when compared with the sequential acquisition in PET/CT where minor head movements can cause misalignment. There is evidence in the literature that 68-Ga DOTA-TATE PET-imaging can serve as a surrogate marker for evidence of invasion into the vessel wall and thereby possibly detects early, developing atherosclerotic plaque. Thus, combined PET and MR with 68-Ga DOTA-TATE should be a promising imaging tool to screen and characterize patients at risk for radiation induced carotid injury.
In this study, DOTATATE-PET/MR will be performed in up to 60 patients with a history of radiation therapy for head and neck squamous cell carcinoma over 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head & Neck Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI scan with 68Ga DOTATATE
Arm Type
Other
Arm Description
PET/MRI scan with 68Ga DOTATATE of carotid arteries in in patients following head and neck radiation therapy
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MRI of carotid arteries with 68Ga DOTATATE
Intervention Description
PET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy
Primary Outcome Measure Information:
Title
Validity of PET/MRI with 68Ga DOTATATE of carotid arteries
Description
Macrophage activity detected by 68Ga DOTATATE PET/MRI of carotid arteries in patients at risk for vascular events post radiation of head and neck squamous cell carcinoma.
Time Frame
complete of enrollment, an average of two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
previously treated with radiation for head and neck malignancy;
Age Group: ≥30 years;
Patients who have no contraindications to PET/MRI;
No allergy to contrast agents.
Exclusion Criteria:
Pregnant females;
Age group: < 30 years;
Allergy to MR contrast agents;
Pacemakers/ICD/Claustrophobic patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Veit-Haibach, MD
Phone
416-340-4800
Ext
6085
Email
Patrick.Veit-Haibach@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach
12. IPD Sharing Statement
Learn more about this trial
Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy
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